Commissioning and Qualification Manager

At QbD Group, we offer knowledge and tailored (software) solutions in development, clinical, regulatory & compliance, production, and distribution for companies active in Pharma, ATMP, and Medical Devices/IVD. We are always looking for the next QbD’er in Qualification & Validation.

👉 Both employees and FREELANCERS are welcome to apply for this opportunity.

What do we expect from you as a C&Q Lead?

As a Commissioning & Qualification (C&Q) Lead, you will take the lead in two major initiatives at a Small Molecule site:

• A site-wide C&Q Remediation Project following current assessments and gap analysis
• A capacity expansion project involving a new Spray and Post Dryer unit

Your responsibilities will include:

• Leading qualification & commissioning efforts in both remediation and expansion projects
• Defining C&Q strategy and plans aligned with GMP and Risk-Based C&Q principles
• Ensuring timely execution of documentation, FATs, commissioning, and qualification activities (IQ/OQ/PQ)
• Collaborating with internal and client stakeholders to ensure project alignment
• Supporting audits and regulatory inspections as C&Q subject matter expert
• Coaching validation professionals involved in the project lifecycle

Who are we looking for?

• BSc/MSc degree in Life Sciences, Engineering, or related field
• Minimum 10 years of experience in Commissioning & Qualification within life sciences
• Solid knowledge of Small Molecule manufacturing and Risk-Based C&Q methodology
• Familiarity with GMP, FDA, EMA regulations
• Fluent in English; Dutch is a plus
• Proven leadership and stakeholder management skills
• Analytical, solution-oriented, and able to manage complex project dynamics